Philippines halts sale of dengue vaccine as Sanofi downplays risk

MANILA/LONDON (Reuters) - The Philippines has ordered French drugmaker Sanofi to stop the sale, distribution and marketing of its Dengvaxia dengue vaccine in the country after the company last week warned it could worsen the disease in some cases.

The order comes days after the Southeast Asian nation suspended a government programme to immunize hundreds of thousands of children with Dengvaxia following Sanofi’s findings released last week. Sanofi shares slid more than 1 percent on Tuesday to a 10-month low.

"In order to protect the general public, the Food and Drug Administration immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA," the Philippine government agency said in a statement on its website released late on Monday. bit.ly/2je0L8Y

The World Health Organisation said on Tuesday it supported the decision by the Philippines to suspend vaccinations with Dengvaxia until more information was available. It said its Strategic Advisory Group of Experts on Immunization would meet to review evidence next week.

“Like many others in the Philippines, WHO is awaiting the expert analysis of new data and advice about its implications for use of the vaccine,” the WHO said in a statement on its website.

The Philippine Food and Drug Administration also directed Sanofi to conduct an information dissemination campaign and said all drug establishments should report any incidents if the vaccine was suspected to have caused any deaths or serious illnesses.

Sanofi said the risk of severe dengue occurring in previously uninfected people who were inoculated with Dengvaxia was about two in 1,000 and these individuals recovered with treatment.

“Only one in 800 of all dengue infections (including symptomless infections) could lead to a severe infection, and the increased risk identified from the new analysis translated to two additional cases of ‘severe dengue’ out of 1,000 previously dengue-uninfected people vaccinated over five years of follow-up,” the company said in an emailed statement.

“In this group, all fully recovered with proper medical treatment.”

Sanofi officials said on Monday in Manila that there had been no reported deaths related to the vaccine which was used to immunize nearly 734,000 children aged 9 and over in the Philippines.

They have received at least one dose of the vaccine as part of a government programme that cost 3.5 billion pesos ($69 million).

SEVERE DENGUE CASE

One 12-year old girl in Tarlac province, north of the capital Manila, who completed the three-dose vaccine treatment, showed symptoms of severe dengue, Health Undersecretary Gerardo Bayugo told Reuters by phone.